Bharat Biotech lines up H1N1 cell culture vaccine HN-Vac launch even as swine flu stages a come back in India

The single-shot HN-Vac is to be used only in adults and not approved for use in kids

Bhartat Biotech is planning to launch HN-Vac, the company’s cell culture based vaccine to prevent H1N1 influenza virus even as the swine flu is reportedly making a come back in certain Indian cities following the start of monsoon rains in India.

Bharat Biotech will submit the patient testing data on the H1N1 influenza virus vaccine HN-Vac by the end of July and expects the Drug Controller General of India’s approval for the vaccine by August.

Once approved, Bharat Biotech’s HN-VAC will be the first cell culture vaccine to and the third indigenously developed vaccine to prevent H1N1 influenza a virus in India.

Cell culture based flu vaccines represent a new generation vaccine technology that removes the need for traditional egg based vaccines.

Egg based vaccines are limited by the availability of high quality eggs in millions to manufacture the vaccine and require a cumbersome manufacturing process.

Cell culture based vaccines would enable Bharat Biotech to respond quickly to pandemics and rapidly increase the manufacturing capacity as required, the company said in a press release.

Vaccines are one of the most effective ways to protect people from contracting illness during influenza epidemics and pandemics. H1N1 pandemic influenza is caused by a new virus and virtually everyone is susceptible.

Bharat Biotech has an outlay of INR 70 crores towards product development, manufacturing facilities and R&D facilities for this cell culture based H1N1 vaccine.

Bharat Biotech has received the H1N1 vaccine strains from WHO/CDC centers for the development of HN-Vac.

The final phase of clinical trials on HN-Vac were started already and the final trial report was expected to be submitted for licensure by July 31.

The company’s facility for commercial scale manufacturing readiness was recently inspected by State and Central Government regulatory authorities.

The Hyderabad-based Bharat Biotech International Limited will produce initially 10 million doses of cell culture-based HN-Vac vaccine.

The company has plans to scale up capacity to produce 100 million doses if the demand goes up.

Bharat Biotech also has plans to export the cell-culture vaccine HN-Vac.

Bharat Biotech is yet to decide on the cost of the cellculture vaccine HN-Vac. But the prices would be competitive and affordable, according to the company’s joint managing director Suchitra Ella.

HN-Vac will be administered single dose in the form of an injection only on the basis of a prescription.

HN-Vac is meant only for adults since the current clinical trials have focussed on adults.

The safety of the cell culture HN-Vac vaccine is not yet tested in children and the vaccine could not be used in children unless safety studies were carried out.

Recently, the Serum Institute of India in Pune has launched a nasal spray H1N1 vaccine at the cost of Rs 150 per dose.

Currently available flu vaccines in India which are meant for injection cost between Rs 200 and Rs 300 a dose.

In this context, the nasal spray vaccine is not only convenient for the patient as it does  not require painful injection but cheaper too.

The conventional injectable vaccine for H1N1 often causes convulsion, swelling or fever in some patients.

The nasal spray vaccine contains live attenuated strains of weakened forms of H1N1 virus developed from the H1N1 virus strain which was supplied by WHO to Serum Institute once H1NI was declared pandemic.

This attenuated virus is so weak that it can’t lead to an infection.

Serum institutes nasal spray is a one time vaccine.

The nasal spray H1N1 vaccine will be delivered into the patient’s nose through a device which will be fitted on the top of a syringe.

The vaccine will be administered in each nostrils through a quick spray. Like other vaccines, the nasal spray also help develop anti bodies to protect against H1N1.

The vaccine also generate protective antibodies in the nose and throat besides in the blood.The clinical trials of the spray vaccine were conducted from 3 institutes from Pune and one each from Indore and Ahmedabad.

Zydus Cadila has also recently launched India’s first indigenously made H1N1 swine flu vaccine VaxiFlu-S in the country.

The egg-based, inactivated vaccine based on conventional technology has been developed by the group’s researchers at its Vaccine Technology Centre (VTC) in Ahmedabad.

Zydus Cadila will become the first Indian pharma company to launch its vaccine which will be marketed under the brand name VaxiFlu-S.

In December, India placed an order with the French drug maker Sanofi Pasteur for supplying 1.5 million doses of H1N1 swine flu vaccine.

Despite subsiding in other parts of the world, the H1N1 swine flu is reportedly in comeback trial in India with the onset of of monsoon.

A few cases of deaths and several instances of H1N1 positive cases have been reported in certain pockets in India.